Device Dossier
TRIDENT TRITANIUM HEMISPHERICAL SHELL - Acetabular shell
Device Dossier for TRIDENT TRITANIUM HEMISPHERICAL SHELL - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record, intended…
- GMDN category: Acetabular shell
- Sponsor: Stryker
Intended purpose
A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. Indication: Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Functional description
This Acetabular Shell is the outer portion of a two-piece acetabulum prosthesis. It is sterile, made of Titanium, is pressfit to the pelvis with out the use of cement. Option to use screws for additional fixation. Dome hole plug included in solid shell option. An Acetabular Insert is implanted within to provide an articulating surface for an artificial Femoral Head, part of a Total Hip Arthroplasty (THA). These come in a range of sizes for compatibility and sizing options